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DRIVE SUCCESSFUL AND EFFICIENT GLOBAL
SUBMISSION MANAGEMENT THROUGH A
BALANCED OUTSOURCING MODEL
Naviga8ng the complexi8es of global submission strategies for original and
lifecycle applica8ons demands aJen8on to global submission requirements,
experience in understanding their implica8ons, and tools to implemen8ng
them. A balanced outsourcing model enables a cost-effec8ve submission and
efficient review process for electronic submissions and associated metadata
management.
OUTSOURCE OR AUGMENT YOUR STAFF FOR AN EFFECTIVE,
EFFICIENT, AND COST SAVING REGULATORY SUBMISSIONS PROCESS
With an effective outsourcing submission management strategy, companies can use external
vendors to either manage all agency submissions or augment their internal staff to assist with
different responsibilities as they pertain to the publishing process. With that said, the
submission management and publishing partner should be carefully selected, otherwise the
entire strategy can back-fire, resulting in frustrated teams, increased costs and submission
delays.
✔ “Percep8ve publishing”- document
interpreta8on, guidance on
authoring, and CTD placement
✔ Leaders in content-based submission
documenta8on strategy
✔ Proficiency in Leading Global Submissions (knowledge of global guidances)
✔ Experts at Global Simultaneous Original Applica8ons
✔ Experience with Drug Development and Lifecycle Applica8on submissions
✔ Specialized publishers (Document QC, Readiness, Cross-Referencing,
Hyperlinking strategies, etc.)
WHAT TO LOOK FOR IN A SUBMISSION MANAGEMENT AND PUBLISHING
PARTNER (MAKING THE MOST OF YOUR OUTSOURCED STRATEGY)
Cost savings will come naturally if you select
a qualified partner, selecting a partner on cost
alone will end up costing you more in the
long run and result in submission delays.

2.
OUTSOURCE TO SAVE
AN EXTERNAL SUBMISSION MANAGEMENT PARTNER IS AN EFFECTIVE WAY
TO KEEP YOUR COMPANY FOCUSED ON ITS CORE COMPETENCY OF DRUG
DEVELOPMENT WHILE COST EFFECTIVELY FILING GLOBAL SUBMISSIONS
A typical employee will spend up to 20% of their normal work week completing
general back office work like training, staff mee8ngs, reviews, etc.
EMPLOYEES VS. OUTSOURCE PARTNER
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Using a “qualified” submission management
and publishing vendor can provide flexibility
and knowledgeable specialists at any time, for
any type of global application submission. An
effective outsourcing model provides a
company the ability to only pay for dedicated
work to the service being provided.
WHY ARE COMPANIES PAYING FOR SERVICES
THEY'RE NOT USING?
It is critical that companies are quickly and cost effectively able to complete and file their
submissions without sacrificing quality. Therefore, when considering the submission
management and publishing team, it is essential that the team is specialized in submission
management and is able to rapidly understand the intricacies of the products and its
applications and combine that with the requirements as defined in global guidances. Without
this subject matter expertise, either speed, quality (or potentially both), will be compromised.
In order to maintain such control and ensure high quality deliverables and services,
companies tend to keep these teams – internal. Is that the right approach?
Demand for Submission Management and Publishing services come in peaks and troughs.
Maintaining a fully internal team, means that (1) if the team is staffed for “peaks” then the
company will carry a work-force that is not utilized during troughs and (2) if the company is
staffed for “troughs” then the company will be struggling to meet demands during periods of
workload peaks and in many instances will staff projects with under qualified members just to
get the work done.
A solid Submission Management and Publishing Outsourcing strategy should be established
with a Partner that has “lived inside pharma” and has successfully completed global
submissions on-time and on-budget. Partners, who primarily use off-shore resources, while
initially may seem attractive due to their “low cost”, will ultimately result in higher costs and
delayed submissions due to the amount of re-work caused by inexperience.

3.
Establishing electronic submissions allows re-use of documents and metadata for global
submissions. The development of a global submission strategy allows for reduction of
country specific documents. Paper is the way of the past and companies have to effectively
move forward with eCTD. Several pharma companies are still operating in paper, and those
who have made the transition to eCTD are not capitalizing on the efficiencies of a truly
“Global” submission strategy. While the submission management systems are still behind
(i.e. don’t enable simultaneous global submissions), business processes can be established
and implemented to ensure these efficiencies are realized. A strategic outsourced submission
partner should not only be savvy in electronic submissions and eCTD but also experienced in
simultaneous global submissions; if they are not, then pharma will pay the cost (both $$ and
time) for their inefficiencies.
REDUCE, RE-USE, AND
ELECTRONICALLY SUBMIT
AGENCY REQUIREMENTS: ELECTRONIC SUBMISSIONS
FDA will require all NDA, ANDA, BLA and Master File submissions be in eCTD
format by MAY 5, 2017. All Commercial IND submissions will be required in
eCTD format by MAY 5, 2018. Over 70% of the submissions CDER receives (other
than master files) are already in eCTD. The agency wants them all in eCTD format.
Using the FDA electronic submissions gateway is required for all eCTD
submissions under 10 GB. Using electronic submissions with the gateway provides
multiple acknowledgements of the receipt and processing of the submissions to allow
for efficient review.
eCTD submissions for Centralised submissions to the
EMA are required and highly recommended for Mutual
and Decentralised procedure submissions. By
OCTOBER 2018 the European Union Clinical Trial
Regula8on EU No. 536/2014 will require submission
of Clinical Trial Applications for all member states be
submitted electronically through the portal.
Japan, Canada, Switzerland, Australia, New Zealand,
Saudi Arabia, ASEAN, and many more countries require
or accept different electronic submissions.
ELECTRONIC SUBMISSIONS ALLOWS COMPANIES TO MEET AGENCY
REQUIREMENTS / RECOMMENDATIONS AND ENABLE EFFICIENT REVIEWS
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4.
NEW FDA MODULE 1
The new FDA eCTD M1 allows for submission of advertising and promotional
materials. FDA accepted the new M1 in June 2015. After a 24-month implementation
period of the final publication of the guidance, paper copies will no longer be accepted.
STAYING CURRENT ON ALL CHANGING REGULATIONS AND REQUIREMENTS
IS NECESSARY FOR TECHNICAL ACCEPTANCE AND EASE OF REVIEW
GET AHEAD OF THE REGULATIONS
NEW ECTD 4.0
The next version of the eCTD will include:
• New attributes and keyword
• Additional lifecycle operators
• Document ordering in the XML
• Group titles for Module 4
• Two-way communication
• Additional M1 changes for all regions
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FDA TECHNICAL CRITERIA
After December 17, 2016, all studies conducted must
be performed using the standardized submission
formats. Any study submitted to a marketing
application must include a trial data summary dataset.
For Commercial INDs studies submitted will need the
summary dataset in 2017.
IDMP IN EU: SPOR
The IDMP implementation in the EU will be known as
SPOR for Substance, Product, Organization, and
Referential. As a benefit to Industry to implement SPOR,
there is a proposal to the EMA that Type I variations
could be solely submitted as metadata to the IDMP
information instead of an eCTD submission. SPOR
replaces xEVMPD in 2018 and is required for all
approved drugs in the EU. In 2019, IDMP information
will be required for all development products.

5.
For more information, please contact:
Mike Swalina
Partner
Pyxa Operations Practice Lead
mswalina@pyxasolutions.com
610-427-9570
Pyxa Solu.ons is
comprised of a
dynamic team of
management
consultants and
R&D subject ma@er
experts specializing
in cross-func.onal
R&D delivery
stemming from
ac.vi.es led by
Regulatory Affairs
ABOUT PYXA
Dalia El-Sherif, PhD
Partner
Pyxa Consulting Practice Lead
delsherif@pyxasolutions.com
610-909-8831
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Contributing Author
Frank Faunce
Principal Consultant
Pyxa Solutions, LLC
ffaunce@pyxasolutions.com
617-251-4402
Let us support you in leading your your submission work /
tools, document preparation, report publishing, submission
publishing, validation and submissions to the agencies.
Pyxa is managed by a team of three seasoned
partners and comprised of a solid team of
consultants with prior blended exper.se in industry
and management consul.ng.
Pyxa takes pride in its successful delivery of global
submissions, with unbeatable turn-around times and quality
deliverables at a matchless cost. Our experience comes from
forming and leading Submission Management teams
internal to major pharma companies.
Pyxa Solutions provides project management for the
successful delivery of global original and lifecycle
submissions. Our staff offers global submission guidance
interpretation and document authoring support for paper,
eCTD and NeeS submission compilation, publishing and
delivery.